Label: BLOWFISH- aspirin, caffeine tablet, effervescent
- NDC Code(s): 75920-0464-1, 75920-0464-2, 75920-0464-4, 75920-0464-8
- Packager: Rally Labs LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated June 21, 2017
If you are a consumer or patient please visit this version.
- Active ingredients
Aspirin 500 mg (NSAID*)Close
Caffeine 60 mg
*Nonsteroidal anti-inflammatory drug
Caffeine…Alertnes aid/Pain reliever aid
- for the temporary relief of minor aches and pains associated with a hangover
- helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover
- also for the temporary relief of headaches or body aches and pains alone
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product. If changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reyes syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- facial swelling
Stomach bleeding warning:
This product contains a nonsteroidal anti-inflammatory drug (NSAID) which may cause severe stomach bleeding. The chance is higher if you
are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
- Do not use
- if you have ever had an allergic reaction to aspirin or any other pain reliever/fever inducer
- in children under 12 years of age
- Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
- you have a sodium-restricted diet
- Ask a doctor or phamacist before use if you are
taking a prescription drug for
- When using this product
the recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, irritability, sleeplessness, and occasionally rapid heart beat.
- for occasional use only. Do not use for more than 2 days for a hangover unless directed by a doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to occur, consult a doctor.
- Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
pain lasts for more than 10 days or gets worse
new symptoms occur
redness or swelling is present
ringing in the ears or a loss of hearing occurs
- If pregnant or breastfeeding
ask a health professional before use. It is especially important not to use aspiring during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.Close
- Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.Close
- upon waking, fully dissolve 2 tablets in 16 oz. of water and drink
- do not exceed recommended dosage
Adults and children 12 years and over
(up to 60 years of age)
2 tablets every 6 hours, as needed, or as directed by a doctor. Do not exceed 8 tablets in 24 hours Adults 60 years and over 2 tablets every 6 hours, as needed, or as directed by a doctor. Do not exceed 4 tablets in 24 hours Children under 12 years Do not use
- Other information
- each tablet contains: sodium 406 mg
phenylketonurics: contains phenylalanine 12.6 mg per tablet
store at room temperature (59–86°F). Protect from excessive heat.
- Inactive ingredients
acesulfame potassium, anhydrous citric acid, aspartame, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonateClose
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
PAIN RELIEVER • ALERTNESS AID
Contains Aspirin (NSAID) and Caffeine
12 EFFERVESCENT TABLETS
P/N: 6039A R: 01/12
DO NOT USE IF PRINTED PACKETS ARE TORN OR PUNCTURED
Own the night.
Save the day.
WAKE up with a hangover.
DROP Blowfish in water.
DRINK when fizzing stops.
FORGET your hangover.
Distributed by Rally Labs LLC
P.O. Box 20094, New York, NY 10014
P/N: 6040A R: 01/12
- INGREDIENTS AND APPEARANCE
aspirin, caffeine tablet, effervescent
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75920-0464 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 60 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) DOCUSATE SODIUM (UNII: F05Q2T2JA0) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75920-0464-1 2 in 1 BOX; Type 0: Not a Combination Product 07/23/2011 2 NDC:75920-0464-8 12 in 1 BOX; Type 0: Not a Combination Product 07/23/2011 3 NDC:75920-0464-2 20 in 1 BAG; Type 0: Not a Combination Product 11/30/2017 4 NDC:75920-0464-4 40 in 1 BAG; Type 0: Not a Combination Product 11/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/23/2011 Labeler - Rally Labs LLC (965453108) Establishment Name Address ID/FEI Business Operations Tower Laboratories Ltd 001587203 manufacture(75920-0464)